A Prospective, Single-Arm, Real-World Study to Evaluate of the Efficacy and Safety of Karvol Plus Capsules in the Management of Nasal Congestion and Associated Symptoms in Patients with Common Cold, Allergic Rhinitis or Sinusitis
Overview
- Phase
- Post Marketing Surveillance
- Status
- Not yet recruiting
- Sponsor
- Indoco Remedies Limited
- Enrollment
- 250
- Locations
- 3
- Primary Endpoint
- Change in Total Nasal Symptom Score (TNSS).
Overview
Brief Summary
This is a prospective, single-arm, real-world study designed to evaluate the efficacy and safety of Karvol® Plus Capsules in patients suffering from nasal congestion and associated symptoms due to the common cold, allergic rhinitis, or sinusitis. Approximately 250 eligible subjects will be enrolled at baseline (Day 0) and receive Karvol® Plus Capsules. Participants will either visit the site or receive telephonic follow-up daily until Day 5. The primary endpoint is the change in Total Nasal Symptom Score (TNSS) from baseline to end of treatment. Safety will be assessed through monitoring of adverse events. Data collection includes demographics, medical history, clinical symptoms, treatment compliance, and safety outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults aged 18 to 65 years.
- •Onset of nasal congestion and associated symptoms due to common cold, allergic rhinitis, or sinusitis within the past 48 hours prior to enrolment.
- •Willing and able to provide written informed consent.
- •Willing and able to comply with study procedures, including follow-up assessments as required by the study protocol.
Exclusion Criteria
- •Known hypersensitivity or allergy to any of the components of Karvol Plus capsules (e.g., menthol, camphor, eucalyptol).
- •Patients with known history of severe respiratory comorbidities, such as uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
- •Patients currently receiving other nasal decongestants (topical or systemic) within the last 48 hours that may interfere with the assessment of Karvol Plus effectiveness.
- •Any other condition or therapy that, in the investigator’s opinion, may interfere with the study outcomes or pose a safety risk.
Outcomes
Primary Outcomes
Change in Total Nasal Symptom Score (TNSS).
Time Frame: Day 0 to Day 5
Secondary Outcomes
- Reduction in individual symptoms, including nasal congestion, runny nose, nasal itching, sneezing, and sleep disturbance.(Day 0 to Day 5)
- Time to first noticeable relief after using Karvol Plus.(Day 0 to Day 5)
- Patient-reported satisfaction with treatment effectiveness.(Day 5)
- Change in cough severity and impact(Day 0 to Day 5)
- Change from baseline in the severity of “heaviness in head”, as measured by the subject using an 11-point Numeric Rating Scale (NRS).(Day 0 to Day 5)
Investigators
Dr Jayesh Sanmukhani
Clinexcel Research